EP3678139A4 - DEVICE, SYSTEM AND PRODUCTION PROCESS - Google Patents

DEVICE, SYSTEM AND PRODUCTION PROCESS Download PDF

Info

Publication number: EP3678139A4
Authority: EP; European Patent Office
Prior art keywords: production process; production
Prior art date: 2017-08-30
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Pending

Application number

EP18850070.6A

Other languages

German (de)

French (fr)

Other versions

EP3678139A1 (en

Inventor

Hidemasa MIYAUCHI

Hitoshi Kusano

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Pharmabio Corp

Original Assignee

Pharmabio Corp

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2017-08-30

Filing date

2018-08-20

Publication date

2021-06-09

2018-08-20 Application filed by Pharmabio Corp filed Critical Pharmabio Corp

2020-07-08 Publication of EP3678139A1 publication Critical patent/EP3678139A1/en

2021-06-09 Publication of EP3678139A4 publication Critical patent/EP3678139A4/en

Status Pending legal-status Critical Current

Links

Classifications

- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M21/00—Bioreactors or fermenters specially adapted for specific uses
- C12M21/08—Bioreactors or fermenters specially adapted for specific uses for producing artificial tissue or for ex-vivo cultivation of tissue
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/38—Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M1/00—Apparatus for enzymology or microbiology
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M3/00—Tissue, human, animal or plant cell, or virus culture apparatus
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/30—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
- C12M41/36—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of biomass, e.g. colony counters or by turbidity measurements
- G—PHYSICS
- G06—COMPUTING OR CALCULATING; COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
- G06Q50/10—Services
- G06Q50/22—Social work or social welfare, e.g. community support activities or counselling services
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Engineering & Computer Science (AREA)
Chemical & Material Sciences (AREA)
Biomedical Technology (AREA)
General Health & Medical Sciences (AREA)
Zoology (AREA)
Public Health (AREA)
Epidemiology (AREA)
Cell Biology (AREA)
Biotechnology (AREA)
Bioinformatics & Cheminformatics (AREA)
Organic Chemistry (AREA)
Wood Science & Technology (AREA)
Medicinal Chemistry (AREA)
Business, Economics & Management (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Genetics & Genomics (AREA)
Virology (AREA)
Primary Health Care (AREA)
Developmental Biology & Embryology (AREA)
Pharmacology & Pharmacy (AREA)
Immunology (AREA)
General Engineering & Computer Science (AREA)
Sustainable Development (AREA)
Microbiology (AREA)
Biochemistry (AREA)
General Business, Economics & Management (AREA)
Dermatology (AREA)
Medical Informatics (AREA)
Tourism & Hospitality (AREA)
Botany (AREA)
Chemical Kinetics & Catalysis (AREA)
Oral & Maxillofacial Surgery (AREA)
Transplantation (AREA)
Molecular Biology (AREA)
Strategic Management (AREA)
Marketing (AREA)
Human Resources & Organizations (AREA)

EP18850070.6A 2017-08-30 2018-08-20 DEVICE, SYSTEM AND PRODUCTION PROCESS Pending EP3678139A4 (en)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
JP2017165283		2017-08-30
PCT/JP2018/030656 WO2019044559A1 (en)	2017-08-30	2018-08-20	Production device, system, and method

Publications (2)

Publication Number	Publication Date
EP3678139A1 EP3678139A1 (en)	2020-07-08
EP3678139A4 true EP3678139A4 (en)	2021-06-09

Family

ID=65527627

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP18850070.6A Pending EP3678139A4 (en)	2017-08-30	2018-08-20	DEVICE, SYSTEM AND PRODUCTION PROCESS

Country Status (8)

Country	Link
US (2)	US11574709B2 (en)
EP (1)	EP3678139A4 (en)
JP (2)	JPWO2019044559A1 (en)
KR (1)	KR102617342B1 (en)
CN (1)	CN111201025B (en)
AU (2)	AU2018326894B2 (en)
SG (1)	SG11202001704SA (en)
WO (1)	WO2019044559A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JP7474576B2 (en) *	2019-10-04	2024-04-25	株式会社日立製作所	Cultivation device setup method, support device, and culture device
WO2024143445A1 (en)	2022-12-27	2024-07-04	国立大学法人大阪大学	Critical process parameter analysis method, critical process parameter analysis device, and critical process parameter analysis program
WO2024231973A1 (en) *	2023-05-08	2024-11-14	株式会社日立製作所	Information processing device
JP2025140913A (en) *	2024-03-14	2025-09-29	株式会社日立製作所	Management system and management method

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US6944512B2 (en) *	2000-10-09	2005-09-13	Seimens Aktiengesellschaft	Device and method for carrying out the decentralized production of desired products from different starting materials, and an automated process system
AU2003217350A1 (en) *	2002-02-08	2003-09-02	University Of Chile	Proliferated cell lines and uses thereof
US8298054B2 (en) *	2004-02-03	2012-10-30	Xcellerex, Inc.	System and method for manufacturing
US7799273B2 (en) *	2004-05-06	2010-09-21	Smp Logic Systems Llc	Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
JP2008271825A (en) *	2007-04-27	2008-11-13	Hitachi Plant Technologies Ltd	Control factor determination method for culture tank and substance production method using the same
DE102008013073B4 (en)	2008-03-06	2011-02-03	Leonhard Kurz Stiftung & Co. Kg	Process for producing a film element and film element
US9069345B2 (en)	2009-01-23	2015-06-30	Mks Instruments, Inc.	Controlling a manufacturing process with a multivariate model
WO2011106792A2 (en) *	2010-02-26	2011-09-01	Myskin, Inc.	Analytic methods of tissue evaluation
JP2015100309A (en)	2013-11-25	2015-06-04	東京エレクトロン株式会社	Automatic culture system and cell management system
EP3151187A4 (en) *	2014-05-30	2018-01-10	Hitachi, Ltd.	Medicine production support system, and medicine production support method
GB201501326D0 (en) *	2015-01-27	2015-03-11	Optimal Ind Automation Ltd	Apparatus and method for use in a process analytical technology system
CN106591115A (en) *	2017-03-02	2017-04-26	深圳汇创联合自动化控制有限公司	Biological fermentation tank on-line monitoring system

2018
- 2018-08-20 KR KR1020207005687A patent/KR102617342B1/en active Active
- 2018-08-20 AU AU2018326894A patent/AU2018326894B2/en active Active
- 2018-08-20 SG SG11202001704SA patent/SG11202001704SA/en unknown
- 2018-08-20 CN CN201880056485.2A patent/CN111201025B/en active Active
- 2018-08-20 EP EP18850070.6A patent/EP3678139A4/en active Pending
- 2018-08-20 JP JP2019539371A patent/JPWO2019044559A1/en active Pending
- 2018-08-20 US US16/643,305 patent/US11574709B2/en active Active
- 2018-08-20 WO PCT/JP2018/030656 patent/WO2019044559A1/en not_active Ceased
2023
- 2023-01-13 US US18/154,328 patent/US12191006B2/en active Active
- 2023-12-26 JP JP2023219520A patent/JP2024038129A/en active Pending
2025
- 2025-08-26 AU AU2025223745A patent/AU2025223745A1/en active Pending

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BRANKE JUERGEN ET AL: "Industry 4.0 - A vision also for personalised medicine supply chains?", CELL AND GENE THERAPY INSIGHTS, vol. 2, 5 July 2016 (2016-07-05), pages 263 - 270, XP055798667, Retrieved from the Internet <URL:https://discovery.ucl.ac.uk/id/eprint/10041672/1/Farid%20Branke%20Shah%20Industry%204%200%20CellGeneTxInsights%20Accepted.pdf> DOI: 10.18609/CGTI.2016.027 *
HARRISON RICHARD ET AL: "Automating decentralized manufacturing of cell & gene therapy products", CELL AND GENE THERAPY INSIGHTS, vol. 2, no. 1, 10 November 2016 (2016-11-10), pages 489 - 497, XP055796378, ISSN: 2059-7800, Retrieved from the Internet <URL:https://core.ac.uk/download/pdf/288370163.pdf> DOI: 10.18609/cgti.2016.014 *
See also references of WO2019044559A1 *

Also Published As

Publication number	Publication date
US12191006B2 (en)	2025-01-07
US20200402621A1 (en)	2020-12-24
JPWO2019044559A1 (en)	2020-12-24
AU2025223745A1 (en)	2025-09-11
CN111201025A (en)	2020-05-26
AU2018326894A1 (en)	2020-03-26
KR20200040781A (en)	2020-04-20
JP2024038129A (en)	2024-03-19
US11574709B2 (en)	2023-02-07
WO2019044559A1 (en)	2019-03-07
CN111201025B (en)	2024-04-12
SG11202001704SA (en)	2020-03-30
US20230162822A1 (en)	2023-05-25
EP3678139A1 (en)	2020-07-08
KR102617342B1 (en)	2023-12-27
AU2018326894B2 (en)	2025-05-29

Legal Events

Date	Code	Title	Description
2019-03-08	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2020-06-05	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2020-06-05	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2020-07-08	17P	Request for examination filed	Effective date: 20200313
2020-07-08	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2020-07-08	AX	Request for extension of the european patent	Extension state: BA ME
2020-12-09	DAV	Request for validation of the european patent (deleted)
2020-12-09	DAX	Request for extension of the european patent (deleted)
2021-01-08	REG	Reference to a national code	Ref country code: HK Ref legal event code: DE Ref document number: 40026550 Country of ref document: HK
2021-06-09	A4	Supplementary search report drawn up and despatched	Effective date: 20210507
2021-06-09	RIC1	Information provided on ipc code assigned before grant	Ipc: G16C 10/00 20190101AFI20210430BHEP Ipc: G16H 40/20 20180101ALI20210430BHEP
2024-08-02	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: EXAMINATION IS IN PROGRESS
2024-09-04	17Q	First examination report despatched	Effective date: 20240806

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